Non- Essential Amino Acid Requirements and Metabolism in... | NCT02009917

Studies
Non- Essential Amino Acid Requirements and Metabolism in Humans

NCT02009917

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jul 18, 2017Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Healthy Adult Males

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Dec 9, 2013

First Submission Date that Met QC Criteria

Dec 9, 2013

First Posted Date

Dec 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2017

Last Update Posted Date

Jul 18, 2017Actual

Name	Class
Ajinomoto Co., Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Protein is a major structural component of all cells in the body. The nutritional importance of protein is because of their amino acids. 9 are called essential and 11 are called non-essential, based on whether we need to get them from diet. This classification is based on studies done using older techniques. Recent studies suggest that these so called non-essential amino acids play important roles in our body's health. For the first time, this proposal defines an experimental design to examine non- essential amino acid/nitrogen requirements and metabolism in humans using the Indicator Amino Acid Oxidation (IAAO) technique.

The objective of the current study is to examine the application of IAAO technique to determine the non-essential amino acid/nitrogen requirement in adult humans.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
13 Carbon dioxide production	Urine and breath samples will be collected to measure the rate of oxidation of expired breath and flux by enrichment of urine.	8 hours (1study day)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-40 years of age
Male
Classified as normal body weight based on body mass index (BMI) 18.5-25kg/m2
Free of any concurrent illness

Exclusion Criteria:

Men not in good health or have a metabolic, neurological, genetic or immune disorder including diabetes and hypertension
Men who are classified as underweight(<18.5kg/m2), overweight(25-30kg/m2) or obese (>30kg/m2) using the BMI classification)
Men who are allergic to milk, eggs and egg protein

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Physiologically Healthy Adult males, 20-40 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rajavel Elango, Ph.D	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child and Family Research Institute		Vancouver	British Columbia	V5Z4H4	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32879983	Derived	Cooper L, Ball RO, Pencharz PB, Sakai R, Elango R. Dispensable Amino Acids, except Glutamine and Proline, Are Ideal Nitrogen Sources for Protein Synthesis in the Presence of Adequate Indispensable Amino Acids in Adult Men. J Nutr. 2020 Sep 1;150(9):2398-2404. doi: 10.1093/jn/nxaa180.